Thu. Oct 6th, 2022
Brussels, 15 August 2022
See question(s) : P-002627/2022
Answer given by Ms Kyriakides
on behalf of the European Commission
As explained in the reply to written question P-001499/2022, information on hazardous properties of co-formulants is obtained under a number of regulatory frameworks, among them Regulation 1907/2006 (REACH)1. Specific data requirements exist for plant protection products including for co formulants contained therein2.
Under Regulation (EC) No 1107/20093, the assessment of plant protection products (PPP) is primarily the responsibility of Member States, who must verify that applicants provide all the required information. If justified, further information or specific tests can be requested from applicants either for the complete PPP or for the individual components. The Commission has initiated further discussions with the European Food Safety Authority and Member States on the topic and some Member States have already confirmed that they have requested additional information or studies in the context ofevaluations of applications for authorisation.
Commission Regulation (EU) 2021/3834 amended Annex III to Regulation (EC) No 1107/2009, listing 144 co-formulants, which are not acceptable for use in plant protection products – most of these werelisted because of concerns related to long-term toxicity. A draft Implementing Regulation, which will set out a procedure and harmonised criteria for identifying further unacceptable co-formulants to be added to this list is in preparation. The Commission intends to apply the same strict criteria concerning the protection of human andanimal health and the environment for the identification of unacceptable co-formulants as apply for the approval of active substances.
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